via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced the publication of an
article entitled, “Coronary sinus narrowing for the treatment of
refractory angina: a multicentre prospective open-label clinical
study (the REDUCER-I study)” in the September 2021 issue of the
journal EuroIntervention.
The article’s lead authors are Stefan Verheye, MD,
PhD, Cardiovascular Center, ZNA Middelheim Hospital, Antwerp,
Belgium, and Maayan Konigstein, MD, from the Tel Aviv Medical
Center, Tel Aviv, Israel. The publication provides interim results
from the REDUCER-I study investigating patients suffering from
refractory angina treated with the Neovasc Reducer™ (“Reducer”)
system. The REDUCER-I study is a prospective, open-label,
multi-center, international, post-market study, (with a
retrospective component) which collects long-term data of patients
with refractory angina treated with the Reducer. The publication
outlines the overall clinical outcomes of the first 228 patients
enrolled.
The primary efficacy endpoint was the percentage of patients who
experience improvement in their angina symptoms defined as a
reduction in Canadian Cardiovascular Society (“CCS”) grade, a
measure of their disability, at six months as compared to baseline.
The primary safety endpoints are the rate of occurrence of device-
and/or procedure-related periprocedural serious adverse events, and
major adverse cardiac events (“MACE”), a composite of cardiac
death, major stroke and myocardial infarction up to 30 days post
implant.
In the first 228 patients (81% male, 68.3±9.6 years), the
procedural success rate was very high (99%), with a very high
safety profile that translated to only one adjudicated possible
procedural or device-related MACE. Mean CCS class improved from
2.8±0.6 at baseline, to 1.8±0.7 at two years. Improvement in ≥1 CCS
class was observed in 82%, and in ≥2 CCS classes in 31% of patients
at two years. At baseline, 70% of the cohort were disabled at very
minimal physical effort (reported to be in CCS class III-IV); this
portion was reduced to only 15% at follow-up. Additional measured
parameters of functional class and quality of life were also
improved.
“The data published in the REDUCER-I study confirm the high
safety profile of the therapy in patients suffering from refractory
angina. The results also demonstrate sustained improvement in
angina severity and in quality of life up to two
years,” said Prof. Verheye. “I am encouraged that we now
have a therapy to offer patients whom, in the past, had no
treatment options. In properly selected patients, the Reducer
offers hope for a return to a more normal life that is less
hampered by the debilitating symptoms of refractory
angina.”
An accompanying editorial, “Coronary sinus reducer therapy
for refractory angina: is it ready for prime time?” was published
in the same issue of EuroIntervention. Authored by Dr. Michael
Foley, MBBS, BSc and Dr. Rasha Al-Lamee, MBBS, MA, PhD, both from
National Heart and Lung Institute, Imperial College London, United
Kingdom, the editorial states, “The most important additive finding
of REDUCER-I is the real-world procedural success and safety of a
new device.” The authors further suggest that the ongoing
ORBITA-COSMIC study and the upcoming COSIRA-II trial will be
helpful to validate the Reducer device for an “important and often
overlooked clinical group.”
“Publication of the interim results of REDUCER-I is another
meaningful step as we build the evidence necessary to establish the
Reducer as standard of care for patients suffering from refractory
angina,” stated Fred Colen, President & Chief
Executive Officer of Neovasc. “We are encouraged by the
peer-reviewed clinical data that continues to mount supporting
Reducer therapy as a viable treatment option for patients that are
suffering from angina-related chest pain. It’s gratifying to see so
many patients be able to return to the daily living activities that
they have previously avoided.”
About Reducer
The Reducer is CE-marked in the European Union and Under
Investigation in the United States for the treatment of
refractory angina, a painful and debilitating condition that occurs
when the coronary arteries deliver an inadequate supply of blood to
the heart muscle, despite treatment with standard revascularization
or cardiac drug therapies. It affects millions of patients
worldwide, who typically lead severely restricted lives as a
result of their disabling symptoms, and its incidence is
growing. The Reducer provides relief of angina symptoms by altering
blood flow within the myocardium of the heart and increasing
the perfusion of oxygenated blood to ischemic areas of the heart
muscle. Placement of the Reducer is performed using a minimally
invasive transvenous procedure that is similar
to implanting a coronary stent and can be completed
in approximately 20 minutes.
While the Reducer is not approved for commercial use in the
United States, the FDA granted Breakthrough Device designation to
the Reducer in October 2018.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops,
manufactures, and markets products for the rapidly growing
cardiovascular marketplace. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include the Neovasc
Reducer™, for the treatment of refractory angina, which is not
currently commercially available in the United States and has been
commercially available in Europe since 2015, and Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel,
and Europe. For more information,
visit: www.neovasc.com.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com
Forward-Looking Statement Disclaimer
Certain statements in this news release contain
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws that may not be based on historical fact. When used
herein, the words "expect", "anticipate", "estimate", "may",
"will", "should", "intend," "believe", and similar expressions, are
intended to identify forward-looking statements. Forward-looking
statements may involve, but are not limited to, the interpretations
and implications of the REDUCER-I study, the efficacy of the
Reducer as a therapy for patients who suffer from refractory
angina, the procedural safety and success of the Reducer, the
ORBITA-COSMIC study and COSIRA-II trial’s helpfulness to validating
the Reducer, the building of evidence necessary to establish the
Reducer as standard of care for patients suffering from refractory
angina, the mounting supporting of Reducer therapy as a viable
treatment option for patients that are suffering from
angina-related chest pain and the growing cardiovascular
marketplace. Many factors and assumptions could cause the Company's
actual results, performance or achievements to differ materially
from those expressed or implied by the forward-looking statements,
including, without limitation, the doubt about the Company's
ability to continue as a going concern; risks related to the recent
COVID-19 coronavirus outbreak or other health epidemics, which
could significantly impact the Company's operations, sales or
ability to raise capital or enroll patients in clinical trials and
complete certain Tiara development milestones on the Company's
expected schedule; risks relating to the Company's need for
significant additional future capital and the Company's ability to
raise additional funding; risks relating to the sale of a
significant number of Common Shares; risks relating to the
possibility that the Company's common shares (the "Common Shares")
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company's
conclusion that it did have effective internal control over
financial reporting as of December 31, 2020 but not at December 31,
2019 and 2018; risks relating to the Common Share price being
volatile; risks relating to the possibility that the Common Shares
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company's
significant indebtedness, and its effect on the Company's financial
condition; risks relating to lawsuits that the Company is subject
to, which could divert the Company's resources and result in the
payment of significant damages and other remedies; risks relating
to claims by third-parties alleging infringement of their
intellectual property rights; risks relating to the Company's
ability to establish, maintain and defend intellectual property
rights in the Company's products; risks relating to results from
clinical trials of the Company's products, which may be unfavorable
or perceived as unfavorable; the Company's history of losses and
significant accumulated deficit; risks associated with product
liability claims, insurance and recalls; risks relating to use of
the Company's products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more
competitors may develop more effective or more affordable products;
risks relating to the Company's ability to achieve or maintain
expected levels of market acceptance for the Company's products, as
well as the Company's ability to successfully build its in-house
sales capabilities or secure third-party marketing or distribution
partners; risks relating to the Company's ability to convince
public payors and hospitals to include the Company's products on
their approved products lists; risks relating to new legislation,
new regulatory requirements and the efforts of governmental and
third-party payors to contain or reduce the costs of healthcare;
risks relating to increased regulation, enforcement and inspections
of participants in the medical device industry, including frequent
government investigations into marketing and other business
practices; risks relating to the extensive regulation of the
Company's products and trials by governmental authorities, as well
as the cost and time delays associated therewith; risks relating to
post-market regulation of the Company's products; risks relating to
health and safety concerns associated with the Company's products
and industry; risks relating to the Company's manufacturing
operations, including the regulation of the Company's manufacturing
processes by governmental authorities and the availability of two
critical components of the Reducer; risks relating to the
possibility of animal disease associated with the use of the
Company's products; risks relating to the manufacturing capacity of
third-party manufacturers for the Company's products, including
risks of supply interruptions impacting the Company's ability to
manufacture its own products; risks relating to the Company's
dependence on limited products for substantially all of the
Company's current revenues; risks relating to the Company's
exposure to adverse movements in foreign currency exchange rates;
risks relating to the possibility that the Company could lose its
foreign private issuer status under U.S. federal securities laws;
risks relating to the possibility that the Company could be treated
as a "passive foreign investment company"; risks relating to
breaches of anti-bribery laws by the Company's employees or agents;
risks relating to future changes in financial accounting standards
and new accounting pronouncements; risks relating to the Company's
dependence upon key personnel to achieve its business objectives;
risks relating to the Company's ability to maintain strong
relationships with physicians; risks relating to the sufficiency of
the Company's management systems and resources in periods of
significant growth; risks relating to consolidation in the health
care industry, including the downward pressure on product pricing
and the growing need to be selected by larger customers in order to
make sales to their members or participants; risks relating to the
Company's ability to successfully identify and complete corporate
transactions on favorable terms or achieve anticipated synergies
relating to any acquisitions or alliances; risks relating to
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; and risks
relating to anti-takeover provisions in the Company's
constating documents which could discourage a third-party from
making a takeover bid beneficial to the Company's shareholders.
These risk factors and others relating to the Company are discussed
in greater detail in the "Risk Factors" section of the Company's
Annual Information Form and in the Management's Discussion and
Analysis for the three and six months ended June 30, 2021 (copies
of which may be obtained
at www.sedar.com or www.sec.gov). The Company has no
intention and undertakes no obligation to update or revise any
forward-looking statements beyond required periodic filings with
securities regulators, whether as a result of new
information, future events or otherwise, except as required by
law.
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